Despite ongoing efforts to prioritize research and interventions for caregivers of military- and civilian-related TBI, there are currently no measures of health-related quality of life (HRQOL) that are specific to these caregivers. Conversely, patient reported outcomes (PROs) measures of HRQOL have been developed in other populations. For example, the National Institutes of Health (NIH) has made a significant investment to improve PROs through both PROMIS (developed for use in chronic disease) and complementary initiatives. PROMIS and these complementary initiatives are designed to allow scores on one measure to be estimated on the other by the inclusion of common items on both measures; these common data elements are gaining influence in current clinical and research practice. These initiatives have involved development of measures in both the general population and multiple clinical populations. Despite the scope of this innovative work, none of these initiatives has examined HRQOL in caregivers. This is concerning given that a valid caregiver-specific measure of HRQOL is necessary to accurately evaluate clinical and research outcomes. This study will address this omission by testing PROMIS item banks in a large sample of TBI caregivers. This study will also develop new caregiver-specific item banks (TBI-CareQOL) that will be integrated with PROMIS through assessmentcenter.net. Specifically, items will be developed through qualitative analysis from focus groups in caregivers of individuals with either military- or civilian-TBI (n=12 groups). These newly developed items will then be tested in a large, diverse sample of caregivers of individuals with military- and civilian-TBI (n=600). After this testing, a state-of-the-art approach employing both classical and contemporary methods of test construction and validation - including Item Response Theory and computerized adaptive testing technology - will be used to develop a computerized adaptive test that permits brief and precise measurement of clinically relevant symptoms and functional limitations. This proposed project will then validate the TBI-CareQOL and PROMIS in caregivers of individuals with military- and civilian-TBI (n=200). Further, we will examine these measures' sensitivity and responsiveness to change over time. The resulting scale will be appropriate for use with both civilian- and military-TBI caregivers, will be utilized as a primary assessment measure in the Congressionally mandated 15-year longitudinal study of caregivers in the military, and will be introduced at the annual TBI model system meetings as a potential measure for inclusion in their longitudinal study. Ultimately, the findings from this study will provide clinically relevant information to providers, allow for more sensitive assessment of intervention-related change, and maximize the efficiency of clinical interventions. PUBLIC HEALTH RELEVANCE: Although the caregivers of individuals with military- and civilian-related traumatic brain injury (TBI) have been identified as an underserved population, current outcome measures lack the sensitivity needed to target interventions and determine the effectiveness of such interventions on health-related quality of life (HRQOL). The purpose of this study is to develop and validate a sensitive caregiver-specific measure of HRQOL (the TBI-CareQOL). Ultimately, the findings from this study will provide clinically relevant information to providers, allow for more sensitive assessment of intervention-related change, and maximize the efficiency of clinical interventions.